Efficacy and safety of Cerebrolysin in moderate to moderately severe Alzheimer's disease: results of a randomized, double-blind, controlled trial investigating three dosages of Cerebrolysin.

Alvarez XA, Cacabelos R, Sampedro C, Aleixandre M, Linares C, Granizo E, Doppler E, Moessler H

European journal of neurology1 Jan 2011Cited by 46 (Europe PMC)

PMID20500802DOI10.1111/j.1468-1331.2010.03092.xPepBankPUB-20500802

Publisher page PubMedAsk about this study

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study10

10 results from studies that gave the peptide. 10 results from people.

01HumanRandomized controlled trialEfficacy outcome
In moderate to moderately severe Alzheimer's disease, Cerebrolysin had no significant effect on total ADL versus placebo.
In plain wordsIn moderate to moderately severe Alzheimer's disease, Cerebrolysin did not significantly improve total daily activities compared with placebo.
Peptide
Cerebrolysin
Outcome
No significant changeTotal ADL
Study
n = 133
Comparator
Placebo
Analysis
Secondary
Outcome group
Exercise and physical function · Nervous system and cognition
Studied dose
Dose not stated · IV infusion · twelve weeksAs given in this study (human).
Source sentences
Summary
Treatment effects on total ADL and other secondary parameters (MMSE, Trail-making test) were not significant.
2 context sentences(design, population, supporting numbers)
Summary · context
This subgroup analysis assessed safety and efficacy of Cerebrolysin in patients with moderate to moderately severe Alzheimer's disease (AD) (ITT data set: N = 133; MMSE: 14-20) included in a dose-finding study (ITT data set: N = 51; MMSE: 14-25).
Summary · context
patients with AD received 100 ml IV infusions of Cerebrolysin (10, 30 or 60 ml diluted in saline; N = 32, 34 and 35, respectively) or placebo (saline; N = 32) over twelve weeks (5 days per week for 4 weeks and 2 days per week for another 8 weeks).
Report a problemFND-2050080207
02HumanRandomized controlled trialEfficacy outcome
In moderate to moderately severe Alzheimer's disease, Cerebrolysin had no significant effect on MMSE versus placebo.
In plain wordsIn moderate to moderately severe Alzheimer's disease, Cerebrolysin did not significantly change MMSE compared with placebo.
Peptide
Cerebrolysin
Outcome
No significant changeMMSE
Study
n = 133
Comparator
Placebo
Analysis
Secondary
Outcome group
Cognition and memory · Nervous system and cognition
Studied dose
Dose not stated · IV infusion · twelve weeksAs given in this study (human).
Source sentences
Summary
Treatment effects on total ADL and other secondary parameters (MMSE, Trail-making test) were not significant.
2 context sentences(design, population, supporting numbers)
Summary · context
This subgroup analysis assessed safety and efficacy of Cerebrolysin in patients with moderate to moderately severe Alzheimer's disease (AD) (ITT data set: N = 133; MMSE: 14-20) included in a dose-finding study (ITT data set: N = 51; MMSE: 14-25).
Summary · context
patients with AD received 100 ml IV infusions of Cerebrolysin (10, 30 or 60 ml diluted in saline; N = 32, 34 and 35, respectively) or placebo (saline; N = 32) over twelve weeks (5 days per week for 4 weeks and 2 days per week for another 8 weeks).
Report a problemFND-2050080208
03HumanRandomized controlled trialEfficacy outcome
In moderate to moderately severe Alzheimer's disease, Cerebrolysin had no significant effect on the Trail-making test versus placebo.
In plain wordsIn moderate to moderately severe Alzheimer's disease, Cerebrolysin did not significantly change Trail-making test performance compared with placebo.
Peptide
Cerebrolysin
Outcome
No significant changeTrail-making test
Study
n = 133
Comparator
Placebo
Analysis
Secondary
Outcome group
Cognition and memory · Nervous system and cognition
Studied dose
Dose not stated · IV infusion · twelve weeksAs given in this study (human).
Source sentences
Summary
Treatment effects on total ADL and other secondary parameters (MMSE, Trail-making test) were not significant.
2 context sentences(design, population, supporting numbers)
Summary · context
This subgroup analysis assessed safety and efficacy of Cerebrolysin in patients with moderate to moderately severe Alzheimer's disease (AD) (ITT data set: N = 133; MMSE: 14-20) included in a dose-finding study (ITT data set: N = 51; MMSE: 14-25).
Summary · context
patients with AD received 100 ml IV infusions of Cerebrolysin (10, 30 or 60 ml diluted in saline; N = 32, 34 and 35, respectively) or placebo (saline; N = 32) over twelve weeks (5 days per week for 4 weeks and 2 days per week for another 8 weeks).
Report a problemFND-2050080209
04HumanRandomized controlled trialSafety outcome
In moderate to moderately severe Alzheimer's disease, Cerebrolysin was reported as safe and well tolerated.
In plain wordsIn moderate to moderately severe Alzheimer's disease, the study reported Cerebrolysin as safe and well tolerated.
Peptide
Cerebrolysin
Outcome
Not applicableSafety and tolerability
Study
n = 133
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · IV infusion · twelve weeksAs given in this study (human).
Source sentences
Summary
Cerebrolysin was safe and well tolerated.
2 context sentences(design, population, supporting numbers)
Summary · context
This subgroup analysis assessed safety and efficacy of Cerebrolysin in patients with moderate to moderately severe Alzheimer's disease (AD) (ITT data set: N = 133; MMSE: 14-20) included in a dose-finding study (ITT data set: N = 51; MMSE: 14-25).
Summary · context
patients with AD received 100 ml IV infusions of Cerebrolysin (10, 30 or 60 ml diluted in saline; N = 32, 34 and 35, respectively) or placebo (saline; N = 32) over twelve weeks (5 days per week for 4 weeks and 2 days per week for another 8 weeks).
Report a problemFND-2050080210
05HumanRandomized controlled trialEfficacy outcome
In moderate to moderately severe Alzheimer's disease, Cerebrolysin 60 ml significantly improved global clinical function versus placebo at week 24.
In plain wordsIn moderate to moderately severe Alzheimer's disease, Cerebrolysin 60 ml improved global clinical function more than placebo at week 24.
Peptide
Cerebrolysin
Outcome
IncreaseGlobal clinical function at week 24
Study
n = 67
Comparator
Placebo
Outcome group
Overall treatment effect · Nervous system and cognition
Studied dose
60 ml · IV infusion · twelve weeksAs given in this study (human).
Source sentences
Summary
at week 24, Cerebrolysin improved the global clinical function significantly with all three dosages and induced significant improvements in cognition, initiation of activities of daily living (ADL) and neuropsychiatric symptoms at 10-, 30- and 60-ml doses, respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
This subgroup analysis assessed safety and efficacy of Cerebrolysin in patients with moderate to moderately severe Alzheimer's disease (AD) (ITT data set: N = 133; MMSE: 14-20) included in a dose-finding study (ITT data set: N = 51; MMSE: 14-25).
Summary · context
patients with AD received 100 ml IV infusions of Cerebrolysin (10, 30 or 60 ml diluted in saline; N = 32, 34 and 35, respectively) or placebo (saline; N = 32) over twelve weeks (5 days per week for 4 weeks and 2 days per week for another 8 weeks).
Summary · context
Primary efficacy criteria ADAS-cog+ (Alzheimer's Disease Assessment Scale Cognitive Subpart Modified) and CIBIC+ (Clinical Interview-based Impression of Change with Caregiver Input) were assessed 24 weeks after baseline.
Report a problemFND-2050080203
06HumanRandomized controlled trialEfficacy outcome
In moderate to moderately severe Alzheimer's disease, Cerebrolysin 60 ml significantly improved neuropsychiatric symptoms versus placebo.
In plain wordsIn moderate to moderately severe Alzheimer's disease, Cerebrolysin 60 ml improved neuropsychiatric symptoms more than placebo.
Peptide
Cerebrolysin
Outcome
DecreaseNeuropsychiatric symptoms
Study
n = 67
Comparator
Placebo
Outcome group
Psychiatric symptoms · Mental health and mood
Studied dose
60 ml · IV infusion · twelve weeksAs given in this study (human).
Source sentences
Summary
at week 24, Cerebrolysin improved the global clinical function significantly with all three dosages and induced significant improvements in cognition, initiation of activities of daily living (ADL) and neuropsychiatric symptoms at 10-, 30- and 60-ml doses, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
This subgroup analysis assessed safety and efficacy of Cerebrolysin in patients with moderate to moderately severe Alzheimer's disease (AD) (ITT data set: N = 133; MMSE: 14-20) included in a dose-finding study (ITT data set: N = 51; MMSE: 14-25).
Summary · context
patients with AD received 100 ml IV infusions of Cerebrolysin (10, 30 or 60 ml diluted in saline; N = 32, 34 and 35, respectively) or placebo (saline; N = 32) over twelve weeks (5 days per week for 4 weeks and 2 days per week for another 8 weeks).
Report a problemFND-2050080206
07HumanRandomized controlled trialEfficacy outcome
In moderate to moderately severe Alzheimer's disease, Cerebrolysin 30 ml significantly improved global clinical function versus placebo at week 24.
In plain wordsIn moderate to moderately severe Alzheimer's disease, Cerebrolysin 30 ml improved global clinical function more than placebo at week 24.
Peptide
Cerebrolysin
Outcome
IncreaseGlobal clinical function at week 24
Study
n = 66
Comparator
Placebo
Outcome group
Overall treatment effect · Nervous system and cognition
Studied dose
30 ml · IV infusion · twelve weeksAs given in this study (human).
Source sentences
Summary
at week 24, Cerebrolysin improved the global clinical function significantly with all three dosages and induced significant improvements in cognition, initiation of activities of daily living (ADL) and neuropsychiatric symptoms at 10-, 30- and 60-ml doses, respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
This subgroup analysis assessed safety and efficacy of Cerebrolysin in patients with moderate to moderately severe Alzheimer's disease (AD) (ITT data set: N = 133; MMSE: 14-20) included in a dose-finding study (ITT data set: N = 51; MMSE: 14-25).
Summary · context
patients with AD received 100 ml IV infusions of Cerebrolysin (10, 30 or 60 ml diluted in saline; N = 32, 34 and 35, respectively) or placebo (saline; N = 32) over twelve weeks (5 days per week for 4 weeks and 2 days per week for another 8 weeks).
Summary · context
Primary efficacy criteria ADAS-cog+ (Alzheimer's Disease Assessment Scale Cognitive Subpart Modified) and CIBIC+ (Clinical Interview-based Impression of Change with Caregiver Input) were assessed 24 weeks after baseline.
Report a problemFND-2050080202
08HumanRandomized controlled trialEfficacy outcome
In moderate to moderately severe Alzheimer's disease, Cerebrolysin 30 ml significantly improved initiation of daily activities versus placebo.
In plain wordsIn moderate to moderately severe Alzheimer's disease, Cerebrolysin 30 ml improved initiation of daily activities more than placebo.
Peptide
Cerebrolysin
Outcome
IncreaseInitiation of activities of daily living
Study
n = 66
Comparator
Placebo
Outcome group
Exercise and physical function · Nervous system and cognition
Studied dose
30 ml · IV infusion · twelve weeksAs given in this study (human).
Source sentences
Summary
at week 24, Cerebrolysin improved the global clinical function significantly with all three dosages and induced significant improvements in cognition, initiation of activities of daily living (ADL) and neuropsychiatric symptoms at 10-, 30- and 60-ml doses, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
This subgroup analysis assessed safety and efficacy of Cerebrolysin in patients with moderate to moderately severe Alzheimer's disease (AD) (ITT data set: N = 133; MMSE: 14-20) included in a dose-finding study (ITT data set: N = 51; MMSE: 14-25).
Summary · context
patients with AD received 100 ml IV infusions of Cerebrolysin (10, 30 or 60 ml diluted in saline; N = 32, 34 and 35, respectively) or placebo (saline; N = 32) over twelve weeks (5 days per week for 4 weeks and 2 days per week for another 8 weeks).
Report a problemFND-2050080205
09HumanRandomized controlled trialEfficacy outcome
In moderate to moderately severe Alzheimer's disease, Cerebrolysin 10 ml significantly improved global clinical function versus placebo at week 24.
In plain wordsIn moderate to moderately severe Alzheimer's disease, Cerebrolysin 10 ml improved global clinical function more than placebo at week 24.
Peptide
Cerebrolysin
Outcome
IncreaseGlobal clinical function at week 24
Study
n = 64
Comparator
Placebo
Outcome group
Overall treatment effect · Nervous system and cognition
Studied dose
10 ml · IV infusion · twelve weeksAs given in this study (human).
Source sentences
Summary
at week 24, Cerebrolysin improved the global clinical function significantly with all three dosages and induced significant improvements in cognition, initiation of activities of daily living (ADL) and neuropsychiatric symptoms at 10-, 30- and 60-ml doses, respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
This subgroup analysis assessed safety and efficacy of Cerebrolysin in patients with moderate to moderately severe Alzheimer's disease (AD) (ITT data set: N = 133; MMSE: 14-20) included in a dose-finding study (ITT data set: N = 51; MMSE: 14-25).
Summary · context
patients with AD received 100 ml IV infusions of Cerebrolysin (10, 30 or 60 ml diluted in saline; N = 32, 34 and 35, respectively) or placebo (saline; N = 32) over twelve weeks (5 days per week for 4 weeks and 2 days per week for another 8 weeks).
Summary · context
Primary efficacy criteria ADAS-cog+ (Alzheimer's Disease Assessment Scale Cognitive Subpart Modified) and CIBIC+ (Clinical Interview-based Impression of Change with Caregiver Input) were assessed 24 weeks after baseline.
Report a problemFND-2050080201
10HumanRandomized controlled trialEfficacy outcome
In moderate to moderately severe Alzheimer's disease, Cerebrolysin 10 ml significantly improved cognition versus placebo at week 24.
In plain wordsIn moderate to moderately severe Alzheimer's disease, Cerebrolysin 10 ml improved cognition more than placebo at week 24.
Peptide
Cerebrolysin
Outcome
IncreaseCognition at week 24
Study
n = 64
Comparator
Placebo
Outcome group
Cognition and memory · Nervous system and cognition
Studied dose
10 ml · IV infusion · twelve weeksAs given in this study (human).
Source sentences
Summary
at week 24, Cerebrolysin improved the global clinical function significantly with all three dosages and induced significant improvements in cognition, initiation of activities of daily living (ADL) and neuropsychiatric symptoms at 10-, 30- and 60-ml doses, respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
This subgroup analysis assessed safety and efficacy of Cerebrolysin in patients with moderate to moderately severe Alzheimer's disease (AD) (ITT data set: N = 133; MMSE: 14-20) included in a dose-finding study (ITT data set: N = 51; MMSE: 14-25).
Summary · context
patients with AD received 100 ml IV infusions of Cerebrolysin (10, 30 or 60 ml diluted in saline; N = 32, 34 and 35, respectively) or placebo (saline; N = 32) over twelve weeks (5 days per week for 4 weeks and 2 days per week for another 8 weeks).
Summary · context
Primary efficacy criteria ADAS-cog+ (Alzheimer's Disease Assessment Scale Cognitive Subpart Modified) and CIBIC+ (Clinical Interview-based Impression of Change with Caregiver Input) were assessed 24 weeks after baseline.
Report a problemFND-2050080204

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 stopped early · source ClinicalTrials.gov (opens in a new tab)

WithdrawnPhase 4NCT01822951

Cerebrolysin Compared to Donepezil in Patients With Mild to Moderate Dementia of Alzheimer's Type (DAT)

Ever Neuro Pharma GmbHn = 0Completion est. Dec 2016

Alzheimer Disease

Trial page ClinicalTrials.govUpdated 26 Oct 2015

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
14 Oct 2026, 05:02 UTC
Study results updated
Version 1
14 Oct 2026, 01:46 UTC
First added · source update from Europe PMC

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